Hazard Type

Sterility Issue Recalls

10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls

Every Sterility Issue Recall

Sorted by most recent. Click any recall for full details and safety information.

10,814 recalls
High RiskFDA
Davol, Inc., Subs. C. R. Bard, Inc.
Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable ste...
Medical Implants·19 affected·Jan 3, 2014
Medium RiskFDA
Pfizer Inc.
Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.V. infusion only, No latex, No preservative, Made in Ireland...
Injectable Drugs·101,681 affected·Jan 2, 2014
High RiskFDA
Icu Medical, Inc.
7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave" T-Connector, Clamp, Rotating Luer, Part No. A1000, Item...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358. The ICU Needleless Connector is...
Medical Devices·800 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 2791243. The ICU Needleless Connector is a sin...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
78" Ext Set w/2 BCV-Clave¿, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connector, 4 Clamps, Rotating Luer, 3 Exts, Part No. A1000, Item ...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave¿, 3 Clamps, Rotating Luer, Part No. A1000, Item No. 011-A1029 The ICU ...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon Valve, Check Valve, 2 Clamps, Luer Lock, Part No. A1000, ...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, 2 Clamps, Rotating Luer, Part No. A1000, Item No. A1081 ...
Medical Devices·100 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave¿ (Yellow, Green Rings), 4 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCVClave...
Medical Devices·250 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7096-001 The ICU Needl...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device inten...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1071 The ICU Needleless Connector is...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave¿, Orange Ring, 2 Anti Syphon Valves, 0.2 Micron Postive Filter, Clamp, NanoClave¿ TCo...
Medical Devices·250 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector, Anti-Siphon Valve, 2 Clamps, Luer Lock, Part No. A1000, It...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClave¿ Clear (Yellow, Red, Green Rings), 6 Clamps, Rotating Luer...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33071-T, Lot # 27...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave¿ ( Light Blue, Lavender Rings), 3 Anti-Syphon Valves, Rotating Luer, Item #011-A1096,...
Medical Devices·100 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7107-001 The ICU Nee...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, Rotating Luer, Part No. A1000, Item No. K7084-001 The ICU N...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
78" Ext Set w/Check Valve, CLAVE¿ Clear, Remv 2 Gang 4-Way Stopcocks, NanoClave¿, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, 3 Ex...
Medical Devices·1,300 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The ICU Needleless Connector is a single use, st...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/Luer Slip, Part No. A1000, Item No. K7085-001 The ICU Need...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7095-001 The ICU Needleless Connec...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. A1069 The ICU Needleles...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave", 3 Clamps, Luer Lock, Part No. A1000, Item No. K7097-001 The ICU Need...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7088-001 T...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave¿ TConnector, Rotating Luer, Part No. A1000, Item No. A1001 The ICU Needle...
Medical Devices·700 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. K7105-001 The ICU Needl...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Part No. A1000, Item N...
Medical Devices·10,400 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1070 The ICU Needleless Connector is ...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769 The ICU Needleless Connector is a single u...
Medical Devices·69,100 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7103-001 The ICU Needleless ...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B3304-T, Lot # 2791244. The ICU Needleless Connector is ...
Medical Devices·750 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, Clamp, NanoClave¿ T-Connector, Rotating Luer, Item # A1003, Lot # 277381...
Medical Devices·250 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, Luer Slip, Part No. A1000, Item No. 011-A1002 The ICU Nee...
Medical Devices·100 affected·Dec 24, 2013
High RiskFDA
Perrigo Diabetes Care
Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Sets are sterile, non-pyrogenic, single-use...
Diabetes Devices·7,924 affected·Dec 20, 2013
CriticalFDA
Abrams Royal Pharamacy
MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX
Injectable Drugs·74 affected·Dec 19, 2013
High RiskFDA
Abrams Royal Pharamacy
All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX
Drugs·0 affected·Dec 19, 2013
High RiskFDA
Steris Corporation
VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY¿ SixCess 270FP...
Medical Devices·94 affected·Dec 19, 2013
High RiskFDA
Advanced Sterilization Products
STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Sterilization System is a general purpose, low temperature steri...
Surgical Devices·2,366 affected·Dec 16, 2013
High RiskFDA
Advanced Sterilization Products
STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterili...
Surgical Devices·5,584 affected·Dec 16, 2013
High RiskFDA
Zions Rx Formulations Services Llc Dba Rx Formuations Serv.
Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Drive, Mesa, AZ...
Drugs·60 affected·Dec 12, 2013
High RiskFDA
Zions Rx Formulations Services Llc Dba Rx Formuations Serv.
Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East University Dri...
Drugs·95 affected·Dec 12, 2013
High RiskFDA
Zions Rx Formulations Services Llc Dba Rx Formuations Serv.
Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East U...
Drugs·861 affected·Dec 12, 2013
High RiskFDA
Zions Rx Formulations Services Llc Dba Rx Formuations Serv.
Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East Uni...
Injectable Drugs·38 affected·Dec 12, 2013
High RiskFDA
Zions Rx Formulations Services Llc Dba Rx Formuations Serv.
Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949 East Un...
Drugs·1,495 affected·Dec 12, 2013
High RiskFDA
Zions Rx Formulations Services Llc Dba Rx Formuations Serv.
Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5...
Drugs·610 affected·Dec 12, 2013